Xofluza

XOFLUZA® (baloxavir marboxil), 20 mg & 40 mg hard capsules
Swissmedic marketing authorisation number: 67426
Swissmedic marketing authorisation date: 19/02/2020

Marketing authorisation studies (3):

1. CAPSTONE 1 (1602T0831)

Indication: influenza

Phase: III

Summary: Randomised, double-blind, multi-centre, placebo- and active-controlled study to assess the efficacy and safety of a single oral dose of Xofluza in comparison with placebo or oseltamivir in otherwise healthy adult and adolescent (aged ≥12 to ≤64, who weighed at least 40 kg) influenza patients.

Sponsors: Shionogi & Co., Ltd (for Japan/Asia), Shionogi Inc. (USA), Shionogi Ltd. (Australia, New Zealand, South Africa)

2. CAPSTONE 2 (1602T0832)

Indication: influenza

Phase: III

Summary: Randomised, double-blind, multi-centre, placebo- and active-controlled study to assess the efficacy and safety of a single oral dose of Xofluza in comparison with placebo or oseltamivir in adults and adolescents (aged ≥12) with influenza and who are at high risk of complications associated with influenza (e.g. asthma or chronic pulmonary disease, endocrine disorders, heart disease, aged ≥65, metabolic disorders, morbid obesity).

Sponsors: Shionogi & Co., Ltd (for Japan/Asia), Shionogi Inc. (USA), Shionogi Ltd. (Australia, New Zealand, South Africa)

3. 1518T0821 (contents in Japanese, summary report in English)

Indication: influenza

Phase: II

Summary: Study to assess the efficacy and safety of a single oral dose of Xofluza in comparison with placebo in otherwise healthy adults (aged ≥20 to ≤64) with influenza.

Sponsors: Shionogi & Co Ltd.


Publication of the results of clinical trials
The information given above and the links to the clinical data fulfil the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO) and amend the information published in association with the Swiss marketing authorisation for Xofluza. Articles 71-73 TPO apply to all medicinal products that were submitted as of January 2019 and were granted marketing authorisation by Swissmedic. The published data will help doctors and other healthcare service providers to take well-informed decisions on treatment and allow researchers to more easily build on the research carried out by Roche and its partners, as well as that carried out by other researchers, to ensure continued scientific progress.